Polypill-based care

Dr Vanessa Selak from the University of Auckland and colleagues are comparing polypill-based care with usual care among people at high risk of cardiovascular disease. They're investigating if it's better to combine a number of different pills into one so-called polypill.

Transcript

Norman Swan: Still to come, a re-analysis of hormone replacement therapy for younger women.

But before that, another innovation they're looking at in Auckland. It's a controversial concept we've covered before on The Health Report called the polypill.

Vanessa Selak is a public health physician at the University of Auckland.

Vanessa Selak: The polypill is an idea that's been around for quite some time. It is really quite a simple idea, it's just about putting several medications into one tablet or capsule, and I'm particularly interested in the use of a polypill in heart disease because it's a way of trying to improve people's access to those medications.

Norman Swan: You're not talking about the original proposition which was you give everybody, say, over the age of 60 the polypill because we're all at high risk of heart disease, and if you give people aspirin or a blood pressure lowering drug et cetera, it's going to make a difference.

Vanessa Selak: Yes, I think that's a very interesting idea, but my own research is focused around using the polypill actually as a way of improving adherence to guidelines.

Norman Swan: Guidelines?

Vanessa Selak: Yes. In New Zealand we recommend that people who've had a heart attack or a stroke receive antiplatelet, blood pressure lowering and cholesterol lowering treatment. But what we know is that a lot of people don't actually receive those medications, even though we know that they'd benefit from them.

Norman Swan: And what medications are we talking about?

Vanessa Selak: We're talking about aspirin, cholesterol lowering medications, so that is medications like simvastatin or atorvastatin, and we're also talking about blood pressure lowering medications.

Norman Swan: Tell me about the trial that you're doing.

Vanessa Selak: The trial that we're doing is looking at whether or not having access to a polypill will improve adherence to those recommended medications in people who either already had a heart attack or a stroke or people who are at high risk of having one of those events.

Norman Swan: And what are the statistics in terms of the extent to which people, say a year or two after your heart attack, are still taking these medications which in theory could save their life?

Vanessa Selak: The rough rule of thumb is that only about 50% of people are still taking that combination. So it's a real tragedy when you think that these medications will reduce people's chance of having another event or stroke by 50% or so, that they're not all taking that medication. Obviously there are some people who can't take specific medications, but there is such a big gap between what people are recommended to take and what they actually take. There is so much potential for improving people's health and improving the number of people who are living without disability from the heart attack and stroke.

Norman Swan: One of the problems I think with an Indian trial that we've had on The Health Report before with the polypill that was tried there, which was actually in an average risk population, was that they didn't seem to get enough of the medication through the pill. There was some problem by putting all these medications together in one capsule.

Vanessa Selak: The idea of putting all of these medicines into one tablet or capsule is quite a simple one, but the compounds actually can react together, and what that can mean is that sometimes the concentrations that you get in the body may not be what you'd expect if you take the medication separately. That's what we call bioequivalence.

Norman Swan: So how successful have you been in formulating the actual capsule?

Vanessa Selak: We've been working with a drug company to get them to do that, and they've been able to achieve a product that does have bioequivalence, but it has taken quite a lot of time.

Norman Swan: And is this expensive?

Vanessa Selak: Developing a drug so that you have bioequivalence to the separate components does require money, but it is not in the same order of magnitude as developing new drugs from scratch.

Norman Swan: Just tell me a little bit about the trial. How many people are you recruiting and how long does it go before you've got an answer?

Vanessa Selak: We've recruited just over 500 people, and we expect to complete the trial in the middle of next year and we should have an answer towards the end of next year.

Norman Swan: Because all you're wanting to know is do they take the tablet compared to having four bottles of pills on the shelf, because you know if they do it's going to have an effect from other trials.

Vanessa Selak: Yes, exactly. There is so much evidence about the benefit of aspirin, cholesterol lowering and blood pressure lowering medication in people who already had an event that there is no point in replicating that evidence. So if we can demonstrate that the polypill improves adherence (that's whether or not people take the medicine), as well as their blood pressure and cholesterol, then I think that should be satisfactory to convince people of the benefit of this approach.

Norman Swan: And tell me what's in your polypill.

Vanessa Selak: Our polypill contains aspirin, that's an antiplatelet agent, it contains a simvastatin which is a cholesterol-lowering agent, and two blood pressure lowering pills. One is lisinopril, that's an ACE inhibitor. And in addition, one version of the pill contains hydrochlorothiazide which is a diuretic, and the other version contains atenolol, which is a beta blocker, instead of the thiazide.

The different formulations are because the recommended treatment is slightly different depending on whether you've had a heart attack or stroke. If you've had a heart attack, then the recommendation is that one of those blood pressure lowering pills that you take is a beta blocker. The other version contains a thiazide, which is a diuretic, and that is recommended for people who had a stroke, and it's also the more suitable medication for people who haven't had an event but are at high risk of an event.

Norman Swan: Such as people with diabetes.

Vanessa Selak: People with diabetes who have other risk factors that mean that their chance of having a heart attack or stroke is higher.

Norman Swan: Vanessa Selak is a public health physician at the University of Auckland.